MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number	P53-103-R051
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During evaluation and investigation, the implants were not available for analysis.The implants are not expected to be returned for the manufacturer review/investigation as they were disposed of by the user facility.The device manufacturing and inspection records were analyzed for the device.No deviations were noted.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a gorilla mtp plate broke post-operatively.A revision arthrodesis surgery was performed to remove the broken hardware on (b)(6) 2020.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood, co
• MDR Report Key: 10291981
• Report Number: 3008650117-2020-00067
• Device Sequence Number: 2655015
• Product Code: HRS
• UDI-Device Identifier: 00889795009425
• UDI-Public: (01)00889795009425(10)PA78895
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P53-103-R051
• Device Catalogue Number: P53-103-R051
• Device Lot Number: PA7889/5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention